Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Relief from dry mouth survey using questionnaires.
研究概览
简要总结
During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be above 18 years of age.
- •Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
- •Ability to attend visits at the research site
- •Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
- •Have a negative history of radiation therapy to head and neck
- •Agree to abstain from the use of any products for xerostomia other than those provided in the study.
- •Agree to comply with the conditions and schedule of the study.
排除标准
- •Subjects with open mouth sores at study entry.
- •Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
- •Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
- •Subjects currently on medication or treatment for dry mouth/xerostomia
- •Subjects < 18 years of age
- •Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
- •Subjects with soft or hard tissue tumor of the oral cavity.
- •Presence of severe gingivitis
- •Chronic disease with concomitant oral manifestations other than xerostomia
- •Subjects with conditions the investigator may feel will interfere with the condition under study.
研究组 & 干预措施
Test Oral Spray
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
干预措施: Test Oral Spray (Device)
Placebo Oral Spray
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their placebo mouth spray, 2 times daily (morning and evening), for the 4 week duration of the study.
干预措施: Placebo Oral Spray (Device)
结局指标
主要结局
Relief from dry mouth survey using questionnaires.
时间窗: 9 weeks
Evaluate patients' perception of efficacy of a new mouth spray compared to a placebo in reducing the symptoms of dry mouth in Sleep Apnea patients. Survey will be done by distributing diaries with daily, weekly and end of study questionnaires.
次要结局
未报告次要终点